Part 2 of 3-part blog about: Cleanroom classification – qualification – monitoring According to EU GMP Annex 1, Rev. 12 draft
The definition for cleanroom qualification is: “The overall process of assessing the level of conformity of a classified cleanroom to its intended use.” This means that the classification is part of the qualification.
The qualification methods are listed in EU GMP Annex 15 and all verifications must comply with the test methods in ISO 14644-3:2019.
Qualifications verification
The next point to consider is what checks are required for cleanroom classification.
First, it is important to understand that airborne and surface microbial contamination must be measured in both resting and operational states.
Next, the number and location of sampling points should be based on a documented risk assessment. This is not the same RA for microbial monitoring. This RA is intended to create a microbial map that characterizes the cleanroom.
Requalification
The requalification must be carried out at least after the following deadlines:
- A & B: at least every 6 months
- C & D: at least every 12 months
The new draft Annex also specifies the required requalification tests, and after changes or exceptional events the cleanroom must be requalified.
Find out how our consulting services team can help you classify and qualify cleanrooms.
Would you like to read more? Jump to other published posts in this series:
Part 1 of 3: Cleanroom Classification
Part 2 of 3: Cleanroom Qualification (You are here!)
Part 3 of 3: Cleanroom Monitoring
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